Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject
DUAL
An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppressed Plasma Viremia
2 other identifiers
interventional
249
1 country
21
Brief Summary
This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2014
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFebruary 14, 2017
June 1, 2016
1.8 years
May 27, 2014
February 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with undetectable viral load
Undetectable viral load \<50 copies/ml according to the FDA snapshot algorithm
week 48
Secondary Outcomes (9)
Proportion of patients with undetectable viral load
Week 24
Proportion of patients with viral load < 200 copies/ml
week 48
Proportion of patients who present viral load ≥ 50 copies /ml one time
From basal visit until week 48 visit
Proportion of patients who present viral load ≥ 50 copies /ml more tan two times
From basal visit until week 48 visit
Proportion of patients who maintained viral load < 50 copies/ml in all determinations
week 48
- +4 more secondary outcomes
Other Outcomes (2)
Proportion of genotypic resistance mutations
Week 48
Change in proportion of genotypic resistance mutations
week 48
Study Arms (2)
Darunavir/Ritonavir + 2 nucleos(t)idos
ACTIVE COMPARATORDarunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)
Darunavir/ritonavir + Lamivudine
EXPERIMENTALDarunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)
Interventions
Darunavir/ritonavir (800/100 mg): QD (quaque die )
Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD
Eligibility Criteria
You may qualify if:
- Acceptance to participate in the study, signing the informed consent document before conducting any study procedures.
- Patient with HIV infection older than 18 years.
- Treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening
- Plasma HIV RNA levels below 50 copies / ml for at least 6 months (two separate measurements at least 6 months with viremia \<50 copies / ml between both).
- HbsAg negative
You may not qualify if:
- Pregnant or breastfeeding woman
- Evidence of Lamivudine resistance (any previous genotype with mutation M184V/I or K65R) and/or to darunavir (population genotype show any of the following mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V).
- History of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions:
- History of abandonment of treatment including lamivudine or emtricitabine, with the following exception:
- \- Viral load prior to abandonment was \<50 copies / ml and subsequent reintroduction of the same treatment or another treatment consisting of lamivudine or emtricitabine + a nucleoside + a non-nucleoside returns to maintain viral load below 50 copies / ml .
- Previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine
- Previous treatment with bitherapy or monotherapy with a regimen with a protease inhibitor that is terminated by viral rebound, when the absence of a genotypic resistance test available after viral rebound allow discard the resistance mutations either drug used.
- The use of concomitant medication not permitted
- Presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial
- Any laboratory results of the following: hemoglobin\<8,0 g/dl; neutrophils \<750 cells/µl; platelets \<50.000 cell/µl; creatinine ≥ 1,5 ULN (upper limit of normal)
- Any clinical or analytic event that, in the investigator judgment, condition the patient safety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion SEIMC-GESIDAlead
- Janssen, LPcollaborator
Study Sites (21)
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Spain
Hospital Clinic
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall D'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Complejo Hospitalario de Huelva
Huelva, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Hospital Universitario Fundación Alcorcón
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital universitario Infanta Leonor
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Príncipe de Asturias
Madrid, Spain
Hospital de Mataró
Mataró, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Donostia
San Sebastián, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Related Publications (1)
Pulido F, Ribera E, Lagarde M, Perez-Valero I, Palacios R, Iribarren JA, Payeras A, Domingo P, Sanz J, Cervero M, Curran A, Rodriguez-Gomez FJ, Tellez MJ, Ryan P, Barrufet P, Knobel H, Rivero A, Alejos B, Yllescas M, Arribas JR; DUAL-GESIDA-8014-RIS-EST45 Study Group. Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial. Clin Infect Dis. 2017 Nov 29;65(12):2112-2118. doi: 10.1093/cid/cix734.
PMID: 29020293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jose R Arribas, MD
Hospital Universitario La Paz
- STUDY DIRECTOR
Federico Pulido, MD
Hospital Universitario 12 de Octubre
- STUDY DIRECTOR
Esteban Ribera, MD
Hospital Vall d'Hebron
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2014
First Posted
June 10, 2014
Study Start
July 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
February 14, 2017
Record last verified: 2016-06